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AdvaMed Device Submissions Workshop In Brief

This article was originally published in The Gray Sheet

Executive Summary

New 510(k) paradigm: Level 2 guidance document on 510(k)s is expected to be released by the end of the summer, Office of Device Evaluation Premarket Notification Staff Director Heather Rosecrans tells attendees at AdvaMed's device submissions workshop held June 6-7 in Rockville, Maryland. "We're right at the process of updating the new paradigm, and that's going to go through the GGP [good guidance practices] process. We're going to consider the truthful and accurate...statement in place of the declaration of conformity...with design controls, because there's no end and no beginning and there has been some confusion." Rosecrans highlighted one change for manufacturers submitting 510(k)s: "validation will have to be completed prior to going to market with your device"...

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